Quality Systems Engineer II - CAPA
Boston Scientific · Maple Grove, MN
- Level
- Engineer
- Team
- Quality
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- 7 days ago
The role in 30 seconds
An engineer-level quality role at Boston Scientific (medical devices) in Maple Grove, MN. You will support the Corrective and Preventative Action (CAPA) process at Maple Grove, inclusive of nonconforming events.
- They ask for
- 2+ years
- Tools it names
- Root cause, CAPA, ISO 13485, FDA / GMP
- Day to day
- relocation help
Read from the posting. The full description is below.
From the plant jobs report · week of November 2, 2026
Quality Engineer roles in Minnesota: typical posted base $86k–$128k.
Median of the low and high ends of 46 live postings that list pay, out of 70 quality engineer openings in Minnesota, read from manufacturers' own careers sites.
Minnesota plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 69 other live quality postings in Minnesota.
- Base pay
- Not listed in this posting
- Experience asked
- Less than usual (2+ vs 5+)
Typical $83k–$120k, from 43 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 60%
- Supplier quality 43%
- ✓ CAPA 39%
- Lean 39%
- Six Sigma 37%
- ISO 9001 36%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Boston Scientific
We found 9 people at this company and state: 8 in this kind of role, 1 leaders. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Mackenzie → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Boston Scientific in Maple Grove
10 other open roles at this site · 9 people we found in quality roles at Boston Scientific.
- Quality Technician I - 2nd Shift · Quality · Technician
- Principal Quality Engineer · Quality · Senior
- Facilities Engineer III · Reliability · Senior
- Manufacturing Technician II - Weekend Overnight Shift · Manufacturing · Technician
- Senior Mechanical Engineering Manager - (Electronic Medical Systems) · Reliability · Manager
- Senior Quality Systems Engineer · Quality · Senior
Full description from Boston ScientificAs posted on their careers site.ShowHide
About the role
As a Quality Systems Engineer II, you will support the Corrective and Preventative Action (CAPA) process at Maple Grove, inclusive of nonconforming events.
The Quality Systems Engineer II will support compliance of the CAPA Process to internal
requirements
and external regulations. This includes CAPA Investigations and Product/Material/System Nonconformances. This role partners closely with Maple Grove CAPA team members, investigation owners, and site leadership. They will provide mentorship to Quality team members and cross-functional stakeholders to enable high-quality investigations, robust root cause identification, and sustainable corrective and preventive actions.
Requirements
- ✓Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues
- ✓Acts as an effective team member and/or leader in supporting quality disciplines, decisions, and practices
- ✓Partner with cross-functional stakeholders to drive standardization and adoption of best practices across sites
- ✓Team member of subject matter experts relating to CAPA at the Maple Grove site
- ✓Track actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program
- ✓Support Site, Regional, and Global CAPA initiatives, continuous improvement opportunities and/or projects
- ✓Drive continuous improvement and efficiencies to support a preventive quality culture
qualifications
- ✓Bachelor's degree
- ✓Minimum of 2 years' experience in the medical device or pharmaceutical industry
- ✓Practical understanding of nonconformance and CAPA regulatory
requirements
and best practices
- ✓Understanding of regulations/standards such as 21 CFR 820 and ISO 13485
- ✓Experience leading or supporting cross-functional initiatives or projects
- ✓Strong problem-solving and root cause analysis skills
- ✓Strong communication and stakeholder management skills
- ✓Ability to make sound, risk-based decisions
Preferred qualifications
- ✓Minimum of 2 years' experience in Quality Systems and/or CAPA Management
- ✓Strong interpersonal skills with the ability to collaborate effectively across Quality, Manufacturing, Engineering, Regulatory, and Supply Chain functions
- ✓High attention to detail, organizational skills, and a disciplined approach to compliance and documentation
- ✓Ability to prioritize tasks effectively in a deadline-driven environment
- ✓Proactive problem solver with a continuous improvement mindset
- ✓Ability to manage priorities in a fast-paced environment with strict regulatory timelines
- ✓Hands-on Project Management experience
- ✓Able to work independently and as a contributing team member
- ✓Continuous improvement mindset with a passion for Quality
Minimum Salary: $ 71500
Maximum Salary: $ 135800
For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Show full description ↓Show less ↑
Recruiter: Spencer Gregory Hale
Quality Systems Engineer II
Work model, sponsorship, relocation
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your
will include
- •Mentor cross-functional CAPA teams on:
- •root cause analysis, corrective action plans, and effectiveness verifications
- •using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet critical CAPA phase timelines
- •creating robust, compliant, and timely records, using the electronic CAPA database system
- •Provide guidance on nonconformance investigations to support appropriate scoping, risk assessments, corrections, and material/product containment (including physical segregation/identification).
- •Provide continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device